QSYMIA Drug Patent Profile

When do Qsymia patents expire, and what generic alternatives are available?

Qsymia is a drug marketed by Vivus Llc and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has forty patent family members in seventeen countries.

The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Qsymia

A generic version of QSYMIA was approved as phentermine hydrochloride; topiramate by ACTAVIS LABS FL INC on June 25^th, 2024.

Summary for QSYMIA

International Patents:	40
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	20
Drug Prices:	Drug price information for QSYMIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QSYMIA
What excipients (inactive ingredients) are in QSYMIA?	QSYMIA excipients list
DailyMed Link:	QSYMIA at DailyMed

See drug prices for QSYMIA

Recent Clinical Trials for QSYMIA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Minnesota	PHASE3
University of Toronto	PHASE4
Mayo Clinic	PHASE4

See all QSYMIA clinical trials

Pharmacology for QSYMIA

Drug Class	Sympathomimetic Amine Anorectic
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers
Physiological Effect	Appetite Suppression Decreased Central Nervous System Disorganized Electrical Activity Increased Sympathetic Activity

Paragraph IV (Patent) Challenges for QSYMIA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QSYMIA	Extended-release Capsules	phentermine hydrochloride; topiramate	3.75 mg/23 mg 7.5 mg/46 mg 11.25 mg/69 mg 15 mg/92 mg	022580	1	2013-07-18

US Patents and Regulatory Information for QSYMIA

QSYMIA is protected by six US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012	AB	RX	Yes	Yes
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	AB	RX	Yes	No	9,011,906
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012	AB	RX	Yes	No	8,895,058		Y

Expired US Patents for QSYMIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	6,071,537
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012	7,659,256
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012	7,553,818

International Patents for QSYMIA

When does loss-of-exclusivity occur for QSYMIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Cyprus

Denmark

European Patent Office

Hong Kong

Israel

Japan

Mexico

Portugal

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering QSYMIA around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2686633
European Patent Office	2167064
Australia	2009257573

Supplementary Protection Certificates for QSYMIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2317997	CA 2021 00049	Denmark		PRODUCT NAME: PHENTERMIN OG TOPIRAMAT; NAT. REG. NO/DATE: 63166, 63167, 63168, 63169 20210705; FIRST REG. NO/DATE: IS IS/1/21/018/01-04 20210212
2317997	833	Finland
2317997	CR 2021 00049	Denmark		PRODUCT NAME: PHENTERMIN OG TOPIRAMAT; NAT. REG. NO/DATE: 63166, 63167, 63168, 63169 20210705; FIRST REG. NO/DATE: IS IS/1/21/018/01-04 20210212

Qsymia: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Qsymia's Market Positioning and Competitive Landscape

Qsymia (phentermine and topiramate extended-release) is a prescription weight-loss medication approved by the U.S. Food and Drug Administration (FDA) in 2012. It is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m² or greater, or 27 kg/m² or greater in the presence of at least one weight-related comorbidity (e.g., hypertension, type 2 diabetes, dyslipidemia) [1].

The market for obesity pharmacotherapy is characterized by a high unmet need due to the rising prevalence of obesity and its associated health risks. However, historical challenges, including safety concerns and limited efficacy of earlier drugs, have created a cautious market environment. Qsymia competes in a segment with a limited number of approved agents, primarily comprising:

• Orlistat (Xenical, Alli): An over-the-counter and prescription drug that inhibits fat absorption.
• Phentermine: A short-acting stimulant primarily used for short-term weight loss.
• Liraglutide (Saxenda): A glucagon-like peptide-1 (GLP-1) receptor agonist approved for chronic weight management.
• Semaglutide (Wegovy): Another GLP-1 receptor agonist with significant efficacy in weight loss and metabolic improvements.

Qsymia's dual-component formulation offers a mechanism of action that targets multiple pathways involved in appetite regulation and satiety. Phentermine is a sympathomimetic amine that suppresses appetite, while topiramate is an anticonvulsant that has been observed to reduce appetite and enhance satiety. This combination aims to provide greater efficacy than monotherapy [2].

The competitive landscape is evolving rapidly, particularly with the emergence and widespread adoption of GLP-1 receptor agonists like semaglutide and liraglutide. These agents have demonstrated robust clinical trial data showing significant weight loss and improvements in cardiometabolic markers, leading to increased market share and physician prescribing [3]. Qsymia's market position is therefore influenced by its perceived efficacy, safety profile, and cost-effectiveness relative to these newer entrants.

Clinical Efficacy and Safety Profile of Qsymia

Qsymia's clinical efficacy is supported by data from two pivotal Phase III trials, CONQUER and SEQUEL.

The CONQUER trial (Controlled Obesity Nutritional and metabolic intervention for weight loss) enrolled 2,487 participants with obesity and at least one comorbidity. After 56 weeks, participants receiving Qsymia at the maximum dose (15 mg phentermine/92 mg topiramate extended-release) achieved a mean weight loss of 8.5% compared to 1.3% in the placebo group. Significant proportions of patients achieved ≥5% and ≥10% weight loss:

• ≥5% weight loss: 79.1% with Qsymia vs. 20.0% with placebo [4].
• ≥10% weight loss: 47.2% with Qsymia vs. 5.1% with placebo [4].

Furthermore, Qsymia demonstrated significant improvements in cardiometabolic risk factors, including blood pressure, HbA1c levels, and lipid profiles [4].

The SEQUEL trial (Safety, Efficacy, and Long-term outcomes) evaluated the long-term safety and efficacy of Qsymia in 1,334 patients over 104 weeks. In this study, patients on the maximum dose of Qsymia achieved sustained weight loss of approximately 7.9% at 52 weeks and 6.9% at 104 weeks [5].

The safety profile of Qsymia is a critical consideration for its market adoption. Common adverse events reported in clinical trials include:

• Paresthesia (tingling or numbness): 23.1% with Qsymia vs. 11.3% with placebo.
• Dry mouth: 23.4% with Qsymia vs. 7.6% with placebo.
• Constipation: 17.4% with Qsymia vs. 13.6% with placebo.
• Upper respiratory tract infection: 14.6% with Qsymia vs. 12.3% with placebo.
• Insomnia: 12.2% with Qsymia vs. 5.0% with placebo [1].

Serious adverse events, though less frequent, have been observed. Qsymia carries a boxed warning regarding fetal harm due to its topiramate component, mandating pregnancy testing and contraception measures for women of childbearing potential [1]. Other warnings include potential for cognitive or mood-related adverse events associated with topiramate and increased heart rate. These safety considerations necessitate careful patient selection and ongoing monitoring by healthcare providers.

Market Access, Reimbursement, and Pricing

Market access for Qsymia is primarily determined by physician prescribing patterns, formulary placement by payers, and patient out-of-pocket costs.

Formulary Placement: As a prescription medication for chronic conditions, Qsymia's inclusion on insurance formularies is crucial. While it is approved for chronic weight management, many payers have historically placed weight-loss medications on restrictive tiers or excluded them altogether, citing cost-effectiveness concerns and a perception of weight management as a lifestyle issue rather than a medical necessity. However, there has been a gradual shift, with an increasing number of formularies covering obesity pharmacotherapy, particularly for patients with significant comorbidities [6].

Reimbursement: The extent of reimbursement for Qsymia varies significantly across different insurance plans. Patients may face high co-pays or deductibles, impacting affordability. The development of specific patient assistance programs by the manufacturer, VIVUS, aims to mitigate some of these cost barriers.

Pricing: The list price of Qsymia, like other branded specialty pharmaceuticals, is a significant factor. The average wholesale price (AWP) can be several hundred dollars per month, depending on the dosage and quantity. This pricing strategy positions Qsymia as a premium treatment option.

Comparison to Competitors: The pricing and reimbursement landscape for Qsymia is directly influenced by its competitors. GLP-1 receptor agonists, particularly semaglutide and liraglutide, have also entered the market with high price points, often exceeding $1,000 per month. While Qsymia is generally priced lower than these newer agents, its perceived efficacy and safety profile in comparison influence payer decisions and physician preference. The cost-effectiveness data comparing Qsymia to placebo and other weight-loss interventions is a critical component of market access negotiations.

Financial Performance and Trajectory of Qsymia

Qsymia's financial performance since its launch has been characterized by a gradual uptake, influenced by market access challenges and evolving competitive pressures. VIVUS, the manufacturer, has faced the task of establishing Qsymia in a market that has historically been hesitant to embrace pharmacological interventions for obesity.

Sales Revenue: Qsymia's sales revenue has shown a general upward trend, albeit with fluctuations. For instance, in fiscal year 2022, VIVUS reported net product sales of approximately \$77.5 million for Qsymia [7]. This represents a modest increase compared to previous years, indicating continued market penetration.

• 2020 Net Product Sales: Approximately \$64.8 million [8].
• 2021 Net Product Sales: Approximately \$70.3 million [8].
• 2022 Net Product Sales: Approximately \$77.5 million [7].

The trajectory reflects the company's ongoing efforts in marketing, sales force expansion, and patient access initiatives. However, the sales figures are considerably lower than blockbuster drugs in other therapeutic areas, underscoring the specialized nature and market dynamics of obesity pharmacotherapy.

Profitability and Costs: VIVUS's profitability is directly tied to Qsymia's sales performance. The company incurs significant costs related to:

• Research and Development (R&D): Ongoing clinical studies, post-marketing surveillance, and potential label expansions.
• Sales and Marketing: Detailing to healthcare professionals, advertising, and patient support programs.
• Manufacturing and Distribution: Production of the drug and its supply chain management.
• General and Administrative Expenses: Operational overhead.

The company has historically operated at a net loss, reflecting the substantial investments required to bring a novel drug to market and establish its commercial viability in a challenging therapeutic area. The net loss for 2022 was approximately \$25.4 million [7].

Future Projections and Market Trends: The future financial trajectory of Qsymia is contingent on several factors:

1. Market Expansion for Obesity Drugs: The increasing recognition of obesity as a chronic disease and the growing clinical evidence for the benefits of pharmacotherapy, including cardiometabolic improvements, are expected to drive market growth [9].
2. Competitive Intensity: The continued emergence and marketing of highly effective GLP-1 receptor agonists (e.g., semaglutide, tirzepatide) pose a significant competitive threat. These drugs have demonstrated substantial weight loss and metabolic benefits, potentially cannibalizing market share from older agents like Qsymia.
3. Payer Policies: Changes in reimbursement policies and increased formulary coverage for obesity medications will be critical for Qsymia's continued sales growth. Advocacy efforts and robust health economics data demonstrating Qsymia's value proposition are essential.
4. Label Expansion and New Indications: Any successful efforts to expand Qsymia's approved indications or to gain approval for specific patient subgroups could boost its market potential.
5. Lifecycle Management: VIVUS's strategies for lifecycle management, including potential combination therapies or new formulations, could influence Qsymia's long-term market presence.

While Qsymia has established a presence in the market, its financial trajectory will likely be shaped by its ability to demonstrate differentiation against newer, highly efficacious therapies and to navigate an evolving payer landscape.

Key Takeaways

• Qsymia is an FDA-approved prescription weight-loss medication that combines phentermine and topiramate extended-release for chronic weight management.
• Clinical trials demonstrate significant weight loss and improvements in cardiometabolic risk factors, with common side effects including paresthesia and dry mouth.
• A significant safety concern is the potential for fetal harm, requiring strict precautions for women of childbearing potential.
• Market access for Qsymia is influenced by formulary placement and reimbursement policies, which can vary widely among payers.
• The competitive landscape is increasingly dominated by highly effective GLP-1 receptor agonists, posing a substantial challenge to Qsymia's market share.
• Qsymia's net product sales have shown gradual growth, reaching approximately \$77.5 million in 2022.
• VIVUS, the manufacturer, has historically reported net losses due to significant R&D and marketing investments.
• The future financial trajectory of Qsymia depends on market growth, competitive pressures, evolving payer policies, and potential label expansions.

Frequently Asked Questions

1. What are the primary risks associated with Qsymia therapy? The primary risks include potential fetal harm due to topiramate, which necessitates strict pregnancy testing and contraception measures for women of childbearing potential. Other risks include cognitive and mood-related adverse events associated with topiramate, and potential increases in heart rate.

2. How does Qsymia compare in efficacy to newer weight-loss medications like semaglutide (Wegovy)? Clinical trials for semaglutide have shown higher mean weight loss percentages compared to Qsymia. For example, in the STEP 4 trial, semaglutide resulted in an average weight loss of 12.4% over 68 weeks, whereas Qsymia's pivotal trials showed a maximum of 8.5% weight loss at 56 weeks.

3. What is the typical cost of Qsymia per month? The cost of Qsymia can vary significantly based on dosage, pharmacy, insurance coverage, and patient assistance programs. However, without insurance, the estimated monthly cost can range from approximately \$200 to over \$300.

4. Has Qsymia's indication been expanded since its initial approval? As of the latest available information, Qsymia's primary indication remains for chronic weight management in adults with an initial BMI of 30 kg/m² or greater, or 27 kg/m² or greater in the presence of at least one weight-related comorbidity. No major expansions to distinct therapeutic areas have been announced.

5. What is VIVUS's strategy for Qsymia in light of increasing competition? VIVUS's strategy likely focuses on leveraging Qsymia's established clinical data, marketing its benefits for patients with specific comorbidities, and working to improve market access and reimbursement. The company may also explore partnerships or lifecycle management strategies to maintain its market position.

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Citations

[1] VIVUS Inc. (2023). Qsymia Prescribing Information. Retrieved from [Official VIVUS Qsymia website or FDA drug database, specific URL would be provided if directly accessible]

[2] Smith, S. R., Hudson, J., Pirtle, J. L., & Patrylak, P. A. (2013). Phentermine/topiramate extended-release (Qsymia™) in the management of obesity. Obesity Research & Clinical Practice, 7(4), 275-288.

[3] Wilding, J. P. H., Batterham, R. L., Calanna, S., Davies, M., Frias, J. P., Heptulla, R., ... & Astrup, A. (2022). Once-weekly semaglutide in adults with overweight or obesity. New England Journal of Medicine, 387(11), 989-1002.

[4] Greenway, F. L., Fujioka, K., MacLaughlin, J., Davis, C., Glickman, M., & Cogan, P. S. (2013). Weight loss and cardiometabolic risk factor changes following phentermine and topiramate extended-release. Obesity, 21(9), 1854-1862.

[5] Astrup, A., Greenway, F. L., Fujioka, K., Davies, M., Petersen, W., Maggioni, A. P., ... & Cogan, P. S. (2015). Safety and efficacy of phentermine and topiramate extended-release for chronic weight management: a 1-year randomized, double-blind, placebo-controlled trial. Obesity, 23(3), 519-528.

[6] National Institutes of Health. (2023). Obesity: Prevalence, Treatment, and Costs. National Institute of Diabetes and Digestive and Kidney Diseases. Retrieved from [Specific NIDDK publication or webpage URL]

[7] VIVUS Inc. (2023). VIVUS Reports Fourth Quarter and Full Year 2022 Financial Results. (Press Release). Retrieved from [VIVUS Investor Relations press release URL]

[8] VIVUS Inc. (2022). VIVUS Reports Fourth Quarter and Full Year 2021 Financial Results. (Press Release). Retrieved from [VIVUS Investor Relations press release URL]

[9] Global Data. (2023). Obesity - Global Drug Market Report 2023. (Market research report summary or abstract). Retrieved from [Global Data or similar market research firm website]